TECNIS® Intraocular Lens for Cataracts

Recruiting at 9 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Must not be taking: Vision-affecting medications

Disqualifiers: Poorly controlled diabetes, uncontrolled eye pressure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but you cannot participate if you are taking medication that may affect vision.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot participate if you are taking medication that may affect vision.

What data supports the idea that TECNIS® Intraocular Lens for Cataracts is an effective treatment?

The available research shows that the TECNIS Eyhance intraocular lens (IOL) is effective in improving vision for cataract patients. One study compared the TECNIS Eyhance lens to a conventional monofocal lens and found that patients with the TECNIS Eyhance lens had better visual outcomes and were more satisfied. Another study focused on the TECNIS Eyhance Toric II lens, which is designed to stay stable in the eye, and found it remained stable over three months. These findings suggest that the TECNIS lenses provide better vision and stability compared to some other options. ^{1 2 3 4 5}

What data supports the effectiveness of the TECNIS® Next-Generation Intraocular Lens treatment for cataracts?

Research shows that the TECNIS Eyhance intraocular lens (IOL) provides improved visual performance and patient satisfaction compared to conventional lenses, and the TECNIS Eyhance Toric II lens demonstrates good rotational stability, which is important for maintaining clear vision. ^{1 2 3 4 5}

What safety data is available for the TECNIS Intraocular Lens for cataracts?

The safety data for the TECNIS Intraocular Lens, including versions like TECNIS Eyhance and TECNIS Eyhance Toric II, has been evaluated in several studies. These studies include assessments of rotational stability, safety, and effectiveness of the lenses, as well as postoperative visual performance and ocular aberrations. The research indicates that these lenses are designed to provide stable and effective outcomes for patients with cataracts, including those with corneal astigmatism. ^{1 2 6 7 8}

Is the TECNIS® Intraocular Lens safe for humans?

The TECNIS® Intraocular Lens, including versions like TECNIS Eyhance and TECNIS Eyhance Toric II, has been evaluated for safety in clinical studies, showing it is generally safe for use in humans. ^{1 2 6 7 8}

Is the TECNIS® Next-Generation Intraocular Lens a promising treatment for cataracts?

Yes, the TECNIS® Next-Generation Intraocular Lens is a promising treatment for cataracts. It aims to improve vision by reducing the need for glasses and enhancing focus. The lens is designed to be stable and effective, especially for people with astigmatism, which is a common eye condition that causes blurred vision. ^{1 2 5 7 8}

What makes the TECNIS Eyhance intraocular lens treatment unique for cataracts?

The TECNIS Eyhance intraocular lens is unique because it offers an extended depth of focus, which can improve vision over a range of distances, potentially reducing the need for glasses after cataract surgery. Additionally, the TECNIS Eyhance Toric II version provides enhanced rotational stability, which is important for patients with astigmatism (an imperfection in the curvature of the eye). ^{1 2 5 7 8}

Research Team

Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Surgical Vision, Inc.

Eligibility Criteria

This trial is for English-speaking adults at least 22 years old with cataracts in both eyes who can sign consent and attend follow-up visits. It's not suitable for those unable to comply with the study procedures or complete questionnaires.

Inclusion Criteria

Patient must understand, read, and write English to complete informed consent and questionnaires

Patient must sign the written informed consent

I am at least 22 years old.

Exclusion Criteria

Patient currently participating in any other clinical study or have participated in a clinical study during the last 30 days

I have uncontrolled eye pressure.

I am on medication that could affect my eyesight.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TECNIS® Next-Generation Intraocular Lens or control lens

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TECNIS® Next-Generation Intraocular Lens

Trial Overview The study compares two types of intraocular lenses (IOLs) used in cataract surgery: a control lens (Model DCB00) and a test lens (Model DEN00V). Participants will be randomly assigned to receive one of these lenses, in a masked setup where the sponsor, subjects, and evaluators do not know which lens is given.

Participant Groups

Group I: Test IOL Experimental Treatment 1 Intervention

DEN00V

Group II: Control IOL Active Control 1 Intervention

DCB00

TECNIS® Next-Generation Intraocular Lens is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as TECNIS Eyhance for:

• Cataract correction

Approved in United States as TECNIS Eyhance for:

• Cataract correction

Approved in Canada as TECNIS Eyhance for:

• Cataract correction

Who Is Running the Clinical Trial?

Johnson & Johnson Surgical Vision, Inc.

Lead Sponsor

Trials

40

Recruited

8,800+

Findings from Research

The TECNIS Eyhance Toric II intraocular lens demonstrated excellent rotational stability, with an average rotation of only 1.34 degrees over 3 months, and no patients required repositioning of the lens.

Patients experienced significant improvements in visual acuity and a reduction in refractive cylinder, indicating both efficacy and a good safety profile, as no adverse events were reported during the study involving 50 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotational stability of a new toric intraocular lens with an advanced optical profile. Zeilinger, J., Hienert, J., Ruiss, M., et al.[2023]

In a study of 34 eyes from 17 cataract patients, the TECNIS Eyhance™ intraocular lens (IOL) demonstrated good intermediate visual acuity three months post-surgery, with a mean distance-corrected near visual acuity of 0.42 decimal notation for binocular vision.

The implantation of the Eyhance IOL resulted in a reduced need for additional reading power, with a mean postoperative minimum reading addition of 1.6 diopters, indicating its effectiveness in improving visual performance after cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Postoperative Total Ocular Aberrations After Bilateral Implantation of Monofocal IOL with Extended Depth of Focus in Phacoemulsification. Abd Elghaffar Shehata, M., Hosny, MH., Tolba, DA., et al.[2023]

The Tecnis Eyhance (ICB00) intraocular lens significantly improved uncorrected intermediate visual acuity compared to the conventional monofocal lens (PCB00), with average monocular UIVA of 20/32 versus 20/40 (p < 0.001).

Patients with the Tecnis Eyhance lens reported less difficulty in activities requiring intermediate vision, such as using a computer, while maintaining comparable distance visual acuity to the conventional lens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of visual outcomes after bilateral implantation of an advanced or conventional monofocal intraocular lens. Lopes, D., Loureiro, T., Carreira, R., et al.[2022]

The Tecnis® Eyhance intraocular lens (IOL) demonstrated significantly better uncorrected and distance-corrected intermediate visual acuity compared to the standard Tecnis® 1-piece IOL in a study of 64 eyes from 32 patients after cataract surgery.

Patients with the Tecnis® Eyhance IOL also experienced greater spectacle independence and better tolerance to residual refractive errors, suggesting it may be a more effective option for improving visual outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of new monofocal innovative and standard monofocal intraocular lens after phacoemulsification. Unsal, U., Sabur, H.[2021]

The Tecnis(®) Multifocal Intraocular Lens is designed to enhance vision quality and reduce spherical aberration, aiming to provide patients with a broader range of focus after cataract surgery.

This lens design reflects the growing demand for presbyopia-correcting solutions, highlighting its potential to help patients achieve spectacle independence, which is a key goal in modern cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient acceptability of the Tecnis multifocal intraocular lens. Sood, P., Woodward, MA.[2021]

The TECNIS Eyhance™ intraocular lens (IOL) with slight monovision in the non-dominant eye improved uncorrected intermediate and near visual acuity compared to bilateral emmetropia, with statistically significant results (p = 0.02 and 0.01, respectively).

Despite the visual improvements in the Monovision group, both groups reported similar satisfaction levels and low contrast visual acuity, with 82% of all subjects expressing happiness with their lens choice, indicating the IOL's effectiveness and patient acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Visual Performance and Subjective Outcomes with an Enhanced Monofocal Intraocular Lens When Targeted for Emmetropia or Monovision. Sandoval, HP., Potvin, R., Solomon, KD.[2023]

The TECNIS toric intraocular lenses (IOLs) significantly reduced ocular astigmatism, with a mean reduction of 74.53% in patients requiring lower cylinder correction (0.75 to 1.50 diopters) compared to only 31.61% in those with standard IOLs, indicating their superior efficacy.

A high percentage of patients achieved excellent uncorrected distance visual acuity (UCDVA), with 43.6% of those with TECNIS toric IOLs reaching 20/20 vision or better, demonstrating both safety and effectiveness in treating cataract patients with corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism. Waltz, KL., Featherstone, K., Tsai, L., et al.[2022]

The TECNIS toric II intraocular lens (IOL) demonstrated significantly better rotational stability compared to the previous model (toric I), with less axis misalignment observed at both 1 day and 1 month post-surgery in a study involving 101 patients.

Despite the improved stability of the toric II IOL, there were no significant differences in visual acuity or residual astigmatism between the two IOL models, indicating that the new design primarily enhances stability without compromising other outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Modified Haptics on Surgical Outcomes and Rotational Stability of Toric Intraocular Lens Implantation. Osawa, R., Sano, M., Yuguchi, T., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rotational stability of a new toric intraocular lens with an advanced optical profile. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of Postoperative Total Ocular Aberrations After Bilateral Implantation of Monofocal IOL with Extended Depth of Focus in Phacoemulsification. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative evaluation of visual outcomes after bilateral implantation of an advanced or conventional monofocal intraocular lens. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of new monofocal innovative and standard monofocal intraocular lens after phacoemulsification. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient acceptability of the Tecnis multifocal intraocular lens. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Comparing Visual Performance and Subjective Outcomes with an Enhanced Monofocal Intraocular Lens When Targeted for Emmetropia or Monovision. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Modified Haptics on Surgical Outcomes and Rotational Stability of Toric Intraocular Lens Implantation. [2023]